FDA.reportPublic FDA data

Rap/Tac/CsA Control

Primary DI
00856743007130
Brand
Rap/Tac/CsA Control
Company
MORE DIAGNOSTICS INC
Model
280-2
Catalog number
280-2
Device description
MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of rapamycin, tacrolimus, and cyclosporine.
Published
2018-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050125000RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4More Diagnostics2005-03-18JJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856743007130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856743007130008567430071308567430071300856743007130

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-14 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18007580978info@morediagnostics.com

Regulatory Flags#

DUNS number
829978451
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856743007000Whole Blood Matrix375-B375-B2020-06-17
00856743007116Whole Blood Matrix275-B275-B2020-06-17
00856743007277EV/TAC/CsA Control3053052019-08-06
00856743007284EV/TAC/CsA Control305-1305-12019-08-06
00856743007291EV/TAC/CsA Control305-2305-22019-08-06
00856743007307EV/TAC/CsA Control305-3305-32019-08-06
00856743007017Cardiac Marker Control1501502018-03-30
00856743007024Cardiac Control Marker150-1150-12018-03-31
00856743007031Cardiac Marker Control150-2150-22018-03-31
00856743007048Cardiac Marker Control150-3150-32018-03-31
00856743007055Cyclosporine C2 Control2022022018-04-03
00856743007062MPA Control2402402018-04-05
00856743007079MPA Control240-1240-12018-04-04
00856743007086MPA Control240-2240-22018-04-05
00856743007093MPA Control240-3240-32018-04-05
00856743007109MPA Control240-4240-42018-04-05
00856743007123Rap/Tac/CsA Control280-1280-12018-04-05
00856743007147Rap/Tac/CsA Control280-3280-32018-04-05
00856743007154Rap/Tac/CsA Control2852852018-04-05
00856743007161Rap/Tac/CsA Control285-1285-12018-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700699445193S7620 QUALICHECK 7+, level 0 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445209S7630 QUALICHECK 7+, level 1 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445216S7640 QUALICHECK 7+, level 2 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445223S7650 QUALICHECK 7+, level 3 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445230S7660 QUALICHECK 7+, level 4 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
00850010224497CareSuperb COVID-19 Antigen External ControlAccess Bio Inc.JJY2026-10-01
10673486014112Teco Diagnostics TC-TROL (N) Serum Control Level I HumanTECO DIAGNOSTICSJJY2026-08-25
10673486014129Teco Diagnostics TC-TROL (A) Serum Control Level II HumanTECO DIAGNOSTICSJJY2026-08-25
00850011135556VALIDATELgc Clinical Diagnostics, Inc.JJY2026-07-07
00850011135853ValidateLgc Clinical Diagnostics, Inc.JJY2026-07-07
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlAccess Bio Inc.JJY2026-06-08
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30